Outlook Therapeutics Inc Stock Price, News & Analysis

Outlook Therapeutics (Nasdaq: OTLK) has requested a Type A Meeting with the FDA following a Complete Response Letter (CRL) regarding their ONS-5010 biologics license application. The CRL, issued on August 27, 2025, acknowledged that the NORSE TWO pivotal trial met safety and efficacy endpoints but recommended additional confirmatory evidence for the wet AMD treatment.

ONS-5010 is an investigational ophthalmic formulation of bevacizumab designed to provide a regulated alternative to compounded bevacizumab, which has been used off-label as a first-line wet-AMD treatment. The Type A meeting aims to clarify the specific confirmatory evidence required by the FDA for approval.

Outlook Therapeutics (NASDAQ: OTLK) announced that the FDA has issued a Complete Response Letter (CRL) for ONS-5010/LYTENAVA™ (bevacizumab-vikg), their wet AMD treatment candidate. The FDA cannot approve the application in its current form due to lack of substantial evidence of effectiveness.

The CRL highlighted that while the NORSE TWO trial met its primary endpoint, the NORSE EIGHT trial did not, leading to the FDA's recommendation for additional confirmatory efficacy evidence. Despite this setback in the U.S., LYTENAVA™ has already received Marketing Authorization in the European Union and UK, and has been commercially available in Germany and UK since June 2025 as the first authorized ophthalmic formulation of bevacizumab for wet AMD treatment.

Outlook Therapeutics (NASDAQ: OTLK) reported its Q3 FY2025 financial results and achieved significant milestones. The company recorded its first commercial sales of LYTENAVA™ (bevacizumab gamma) in Europe, marking its transition to a commercial-stage company. For Q3, OTLK reported revenue of $1.5 million and a net loss of $20.2 million ($0.55 per share).

The company has a crucial PDUFA date of August 27, 2025, for ONS-5010/LYTENAVA™ FDA approval in the United States. LYTENAVA™ is now commercially available in Germany and UK for wet AMD treatment, with first patients already dosed. The company ended the quarter with cash and equivalents of $8.9 million.

Outlook Therapeutics (NASDAQ: OTLK), a biopharmaceutical company specializing in bevacizumab treatments for retina diseases, announced its participation in the 8th Annual OIS Retina Innovation Summit. The company's CEO, Bob Jahr, will present during the Innovation Showcase session on July 29, 2025, from 8:35 – 9:35 AM PT in Long Beach, California.

Outlook Therapeutics (NASDAQ:OTLK), a biopharmaceutical company developing bevacizumab treatments for retina diseases, announced its participation in the Virtual Investor "What's Your Story" Summer Spotlight On-Demand Conference. Bob Jahr, the company's newly appointed CEO, shared his professional journey and vision for the company's future in a video presentation.

The presentation is now accessible to investors through the Virtual Investor website and Outlook Therapeutics' investor relations page.

Outlook Therapeutics (NASDAQ: OTLK) has appointed Bob Jahr as its new Chief Executive Officer and Board member. Jahr brings over 20 years of biopharmaceutical industry experience specializing in building and leading commercial teams across various therapeutic areas including rare disease, oncology, and neuroscience.

The appointment comes at a strategic time as Outlook Therapeutics is launching LYTENAVA™ (bevacizumab-vikg) in Europe and awaiting potential FDA approval in the United States. Lawrence A. Kenyon, who served as interim CEO, will continue as Chief Financial Officer and Board member.

As part of his employment agreement, Jahr will receive an inducement grant of options to purchase 800,000 shares of common stock, vesting over four years with 25% vesting in the first year and the remainder monthly over three years.

[ "Strategic timing of CEO appointment coincides with European launch of LYTENAVA™ and pending FDA approval", "New CEO brings extensive commercial leadership experience with multiple billion-dollar assets", "Continued stability with CFO Lawrence Kenyon remaining in his role" ]

Outlook Therapeutics (NASDAQ: OTLK) announced its participation in a Virtual Investor Lunch Break Event scheduled for June 25, 2025, at 12:00 PM ET. The company's leadership team, including Lawrence Kenyon (CFO and Interim CEO), Jeff Evanson (CCO), and Jedd Comiskey (SVP - Head of Europe), will discuss commercial strategy, upcoming milestones, and current activities. The event will feature a moderated discussion followed by a live Q&A session. Investors can access the live video webcast through the Events page on Outlook Therapeutics' website, with a replay available for 90 days after the event.

Outlook Therapeutics (NASDAQ: OTLK) has received Scottish Medicines Consortium (SMC) recommendation for LYTENAVA (bevacizumab gamma) to treat wet age-related macular degeneration (wet AMD) within NHS Scotland. LYTENAVA is the first licensed ophthalmic formulation of bevacizumab for wet AMD in the UK, with 10 years of market exclusivity. The recommendation follows successful clinical trials (NORSE ONE, TWO, and THREE) and the recent commercial launch in the UK. Outlook has partnered with Cencora for global distribution support, aiming to enhance market access in the EU, UK, and potentially the US pending approval.

Outlook Therapeutics (NASDAQ: OTLK) has launched LYTENAVA (bevacizumab gamma), the first and only approved ophthalmic formulation of bevacizumab for wet AMD treatment, in Germany and the UK. This marks a significant milestone as the drug addresses the current practice of using off-label repackaged bevacizumab, which accounts for approximately 2.8 million injections annually in Europe. The company has partnered with Cencora (formerly AmerisourceBergen) for global commercial distribution and plans additional European launches throughout 2025 and 2026. LYTENAVA aims to mitigate risks associated with current off-label bevacizumab use while maintaining the standard of care for retinal diseases.